• Title/Summary/Keyword: Regulatory Guideline

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Effect of Bentonite and Cement on Permeability and Compressive Strength of the Compacted Soil Liner (벤토나이트와 시멘트가 매립장 차수층의 투수성과 압축강도에 미치는 영향(I))

  • Kim, Soo-Moon;Youm, Hee-Nam;Lim, Nam-Woong
    • Journal of Korean Society of Environmental Engineers
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    • v.22 no.3
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    • pp.495-504
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    • 2000
  • This study discussed the optimal use of bentonite and cement for the compacted soil liner of landfill. Techniques employed in this optimization included permeability(by KSF 2322) and compressive strength(by KSF 2314). The optimal amount of these materials to the compacted soil liner was determined in accordance with a regulatory guideline of the government: that is, $k=1{\times}10^{-7}cm/sec$. The testing sods were CL(Clayey Soil) and SM(Sandy Soil), which were classified according to LSCS(Unifed Soil Classify System), The results showed that the optimal amounts of bentonite and cement to mix with the compacted CL soil liner were 5% of bentonite and 5% of cement : namely, $k=9.98{\times}10^{-8}cm/sec$ and ${\sigma}_{28}=1275kg/cm^2$. For the compacted SM soil liner. the optimal amount of bentonite was 15%, in conjunction with 5% of cement : namely, $k=9.86{\times}10^{-8}cm/sec$ and ${\sigma}_{28}=18.72kg/cm^2$. It was concluded that the compacted CL or SM soil liner, with containing the optimal amounts of bentonite and cement showed the acceptable permeability and the compressive strength, referring to a regulatory guideline of the government for construction of the landfill.

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Residents' Usage of Community Facilities by Types of National Rental Apartment Complexes (단지특성에 따른 국민임대주택 커뮤니티시설의 거주자 이용 실태에 관한 연구)

  • Hwang, Yeon-Sook;Chang, Yun-Jung;Son, Yeo-Rym;Chang, A-Ri
    • Korean Institute of Interior Design Journal
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    • v.18 no.5
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    • pp.147-155
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    • 2009
  • The purpose of this study is to examine the residents' preference to community facilities in national rental apartment complexes. Twelve housing complexes were sampled and researched with questionnaire and field-surrey methods. The data from the questionnaire survey were processed with SPSS 14 and analyzed by regional group, size of complex, and arrangement plan of facilities. The complexes are located in two legions, Seoul and Gyounggi province. They were also sorted into three groups by size: less than 500 households, 500 to 1,000, and more than 1,000. Lastly, the complexes were categorized into three types: those where facilities are concentrated in or around a single building, dispersed into several places, and located in residential buildings. The results are as follows: Majority of the community facilities are established outdoor and, therefore, the indoor facilities are relatively more insufficient. Especially, there is a shortage of indoor gymnasium while the demand is increasing. It is partly because there is no regulatory guideline on indoor gym requirements in housing complexes. The resident satisfaction measurement shows significant comparison according to region and complex size. The level of satisfaction with garden/kitchen-garden, pond/fountain/streamlet is higher at the complexes in Gyunggi. The residents of larger complexes give positive feedback about spells facilities while those of smaller complexes are more satisfied with education-related facilities such as library and study. The measurement of resident needs shows significant comparison according to complex size and facility arrangement plan. The residents of smaller complexes are more in need of community facilities. In both regulatory standards and actual condition, community facilities are more insufficient at small complexes with less than 500 households.

Current Perspectives on Emerging CAR-Treg Cell Therapy: Based on Treg Cell Therapy in Clinical Trials and the Recent Approval of CAR-T Cell Therapy (장기이식 거부반응과 자가면역질환 치료제로서의 CAR Treg 세포치료제의 가능성: Treg 세포치료제 임상시험 현황과 CAR T 세포치료제 허가 정보를 바탕으로)

  • Kang, Koeun;Chung, Junho;Yang, Jaeseok;Kim, Hyori
    • Korean Journal of Transplantation
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    • v.31 no.4
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    • pp.157-169
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    • 2017
  • Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.

Development of Guideline for Heuristic Based Usability Evaluation on SaMD (SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발)

  • Jong Yeop Kim;Junghyun Kim;Zero Kim;Myung Jin Chung
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.428-442
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    • 2023
  • In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

Risks Incurred by Release of Animals into the Natural Ecosystem in Korea and Its Risk Management (국내 동물의 야생생태계 방출로 인한 위해성 및 위해성 관리방안)

  • Bang, Sang-Weon;Kim, Ae-Sun
    • Journal of Environmental Policy
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    • v.10 no.1
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    • pp.3-25
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    • 2011
  • Recently, a number of local governments as well as private organizations have spearheaded the release of animals into the natural ecosystem in Korea. In 2002, most of these animals released were mammals and birds, but the parameter was gradually expanded to include fish, amphibians, and invertebrates in addition to mammals and birds in 2007, with an increased overall number of animals released. Such increase has not only posed ecological, economic, and public health risks, but also yielded an increase in damages incurred by releasing animals historically or ecologically alien to a given region without thorough risk assessment. The most significant cause of such risks was a critical lack of risk management and regulatory schemes addressing the release of animals into the natural ecosystem. In stark contrast, developed countries long before established the requisite risk management and regulatory schemes either by complying with the IUCN/SSC's Guidelines for Re-Introductions or devising them independently. In this context, the current study has examined the release of animals into the natural ecosystem in Korea and, based on the investigation, asserted a strong need for proper risk management. Moreover, the study has presented systematic risk management and regulatory schemes suitable for the Korean milieu based on a comparative analysis of those employed in developed countries.

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Changes in China's Rare Earth Industry Policy and their Implications (중국 희토류산업정책의 변화와 정책적 함의)

  • PARK, In-Sop;SONG, Jae-Do
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.71
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    • pp.297-324
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    • 2016
  • China not only has the largest amount of rare earth reserves, but it also produces the most rare earth products. However, China lacks appropriate supervision and management systems of its rare earth industry. The Chinese government's inappropriate mechanisms have been cause for reckless development by national rare earth providers characterized by excessive competition, environmental pollution, and smuggling. In response to the problems, China implemented regulatory measures to restructure the rare earth industry. The Chinese central government intensifies its efforts to control the total quantity of rare earth products and tackle environmental pollution. Six leading conglomerates have been selected to promote the Chinese central government's policy. A new environmental guideline has been drawn up to reduce the discharging of wastewater and air pollution substance. Huge transition and a great influence of its policy changes are expected. These policy changes are bound to entail huge transitions, and the policy is expected to have a great influence in the future structure of the rare earth industry. In consideration of these changes, the Korean government, in collaboration with private enterprises needs to take appropriate measures, such as overseas resources development, R&D expansion, tactical stockpiling, professional manpower training and so on.

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Independent Data Monitoring Committees: Review of Current Guidelines (국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황)

  • Lee, Bo Ram;Lee, Kyung Eun
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.181-186
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    • 2016
  • Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

A Mathematical Model to Evaluate the Radiological Risks for the Reuse of Decommissioning Site (원자력시설 해체부지의 재이용을 위한 방사선학적 리스크 평가모델)

  • Cheong, Jae-Hak
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.4 no.4
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    • pp.353-363
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    • 2006
  • In order to evaluate the potential radiological risks for the reuse of the site after decommissioning of nuclear facilities, a mathematical model was developed and materialized into the Microsoft $Excel{\circledR}$ spreadsheets frame. A set of input parameter values was proposed, which is useful in the preliminary risk screening step before the detailed evaluation with the site-specific data. It appeared that the screening levels calculated by the present model was agreed with the derived concentration guideline limits resulted from RESRAD Ver.6.2 and the German dose criteria for releasing a nuclear site from regulatory control.

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Review: Increasing Marbling Score in Hanwoo via Feeding Vitamin A-Deficient Diets. (비타민 A 결핍을 통한 한우 고급육 생산)

  • Kim, W.Y.;Park, J.K.;Yeo, J.M.
    • Journal of Practical Agriculture & Fisheries Research
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    • v.17 no.1
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    • pp.3-20
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    • 2015
  • Vitamin A exerts a broad range of effects on many essential life processes. But, since vitamin A is known to negatively affect the development of adipocytes, extensive research has been conducted to improve marbling score in beef cattle by feeding vitamin A-deficient diets. In Japan, the method of fattening Wagyu cattle using vitamin A-deficient diets has been widely adapted. Recently, the method of feeding vitamin A-deficient diets in Korean native cattle (Hanwoo) has been spread by feed companies and TMR plants. But proper guidelines in feeding vitamin A-deficient diets should be provided, otherwise it can adversely affect the health of cattle. To maximize marbling score, a controlled level of vitamin A in blood needs to be maintained and the proper period for feeding vitamin A-deficient diets should be adapted. This review was conducted to highlight the regulatory effects of vitamins A on adipocyte differentiation, and offer a potential guideline for improving beef quality grades in Hanwoo.

A Study on Domestic Policy Framework for Application of Carbon Dioxide Capture and Storage(CCS) (이산화탄소 포집 및 저장 실용화를 위한 국내 정책 연구)

  • Chae, Sun-Young;Kwon, Suk-Jae
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.18 no.6
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    • pp.617-625
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    • 2012
  • This study examines the current status and policy development of Carbon Dioxide Capture and Storage(CCS), which is a technology to mitigate climate change, in Korea and foreign countries. It also analyzes IEA CCS regulatory framework as a guideline and provides limitations and implications for marine geological storage in the Republic of Korea. Although CCS master plan is established at national level, related laws are not amended and detailed polices are not yet provided. Established 'Intergovernmental CCS committee' lacks its cooperative mechanism and flexibility. Only limited and segmented economic analyses are performed and funding for large scale of CCS project is not secured. In addition, information sharing is limited and public awareness activities are insufficient. Therefore, this paper provides some policy suggestions on establishing a legal framework based on the 'Marine Environmental Management Act', strengthening the role of intergovernmental CCS committee, conducting CCS economic analysis based on various scenarios, providing economic incentives and public participation strategies, and establishing a specialized agency for information sharing.